MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PERIFIX EPIDURAL KIT; ANESTHESIA CONDUCTION KIT

Model Number CESK

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2018

Event Type  malfunction  

Event Description

An epidural catheter became disconnected during labor when the connector flipped open spontaneously.

• Brand Name: PERIFIX EPIDURAL KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 7990710
• MDR Text Key: 124583163
• Report Number: 7990710
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CESK
• Device Catalogue Number: -
• Device Lot Number: 55484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA